Z-2732-2017 Class II Terminated
FDA device recall Z-2732-2017 was initiated by Nova Biomedical Corporation on June 19, 2017 and is designated Class II. Reason for recall: Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. The recall status is terminated (terminated August 14, 2018). Affected quantity: 179 units (US) and 904 (OUS) Total 1083.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- June 19, 2017
- Termination Date
- August 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 units (US) and 904 (OUS) Total 1083
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana Greece Guatemala Guyana Honduras Hong Kong Hungary ICELAND India Iran Israel Italy Ivory Coast Japan Jordan Kenya Korea Latvia Macedonia Malaysia Mexico Nepal Netherlands Nigeria Pakistan Pakistan Palestine Peru Philippines Poland Puerto Rico Republic of Panama Republica Dominicana Russia Saudi Arabia Slovak Republic Slovenia South Africa Sri Lanka Switzerland Taiwan Thailand The Netherlands Trinidad,W.I. Tunisia Turkey UK Uruguay Vietnam